Evista

OVERDOSE

In an 8-week study of 63 postmenopausal women, a dose of raloxifene HCl 600 mg/day was safely tolerated. In clinical trials, no raloxifene overdose has been reported.

In postmarketing spontaneous reports, raloxifene overdose has been reported
very rarely (less than 1 out of 10,000 [< 0.01%] patients treated). The highest
overdose has been approximately 1.5 grams. No fatalities associated with raloxifene
overdose have been reported. Adverse reactions were reported in approximately
half of the adults who took ≥ 180 mg raloxifene and included leg cramps and
dizziness.

Two 18-month-old children each ingested raloxifene 180 mg. In these two children, symptoms reported included ataxia, dizziness, vomiting, rash, diarrhea, tremor, and flushing, as well as elevation in alkaline phosphatase.

There is no specific antidote for raloxifene.

No mortality was seen after a single oral dose in rats or mice at 5000 mg/kg
(810 times the human dose for rats and 405 times the human dose for mice based
on surface area, mg/m2) or in monkeys at 1000 mg/kg (80 times the
AUC in humans).

Pregnancy, Women Who May Become Pregnant, and Nursing Mothers

EVISTA (raloxifene) is contraindicated in pregnancy, in women who may become pregnant, and in nursing mothers. EVISTA (raloxifene) may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

In rabbit studies, abortion and a low rate of fetal heart anomalies (ventricular
septal defects) occurred in rabbits at doses ≥ 0.1 mg/kg (≥ 0.04 times the
human dose based on surface area, mg/m2), and hydrocephaly was observed
in fetuses at doses ≥ 10 mg/kg (≥ 4 times the human dose based on surface
area, mg/m2). In rat studies, retardation of fetal development and
developmental abnormalities (wavy ribs, kidney cavitation) occurred at doses
≥ 1 mg/kg (≥ 0.2 times the human dose based on surface area, mg/m2).
Treatment of rats at doses of 0.1 to 10 mg/kg (0.02 to 1.6 times the human dose
based on surface area, mg/m2) during gestation and lactation produced
effects that included delayed and disrupted parturition; decreased neonatal
survival and altered physical development; sex- and age-specific reductions
in growth and changes in pituitaryhormone content; and decreased lymphoid compartment
size in offspring. At 10 mg/kg, raloxifene disrupted parturition, which resulted
in maternal and progeny death and morbidity. Effects in adult offspring (4 months
of age) included uterine hypoplasia and reduced fertility; however, no ovarian
or vaginal pathology was observed.

Last reviewed on RxList: 9/26/2007
This monograph has been modified to include the generic and brand name in many instances.